Test 1 Flashcards
Pure Food and Drug Act (1906)
The federal government (Food and Drug Administration, FDA may enforce standards of drug strength and purity as
officially designated by the USP (United States Pharmacopoeia and NF (National Formulary).
prohibits mislabeling or adulteration of drugs
Harrison Narcotic Act (1914)
regulated importation, manufacture, sale, and use of opium cocaine, and marijuana
repealed and superseded by Controlled Substances Act (1970)
Food, Drug, and Cosmetic Act (1938)
enforced by the FDA through registration of all partie involved in the manufacture, sale, and distribution of drugs
required adequate testing of a compound to prevent marketin of a possibly toxic substance. New drugs must be safe as well a pure in order to be introduced into interstate commerce. But thi law still did not require proof of effectiveness
Durham-Humphrey Amendments (1952)
separated drugs into legend (prescription) and nonlegend (nonprescription, over-the-counter) categories. The “legend” must appear on every commercial container of legend drugs: “Caution: Federal Law Prohibits Dispensing without Prescription.”
rules for dispensing legend drugs
Kefauver-Harris Amendments (1962)
- required proof of efficacy as well as safety before any new drug could be placed in interstate
commerce (Thalidomide) - guidelines for conducting clinical trials
- established the Drug Efficacy Study Implementation (DESI)
Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act)
- established rehabilitation programs for drug users
- established control (registration) and enforcement
(DEA) - regulates export and import of controlled substances
What is a Controlled Substance?
Prescription
Potentially addictive
Reinforcing
Physically addicting
Psychologically addicting
Use is controlled by the Federal Government and monitored by both Federal and State Governments
Schedule I
- high abuse potential and no accepted medical use in U.S.
investigational drugs - opiates: heroin, many synthetic derivatives
- hallucinogens: LSD, mescaline, peyote, bath salts
- marijuana (medical marijuana in 21 states an
exception), spice - methaqualone (Quaalude)
Note: More complete listings are found for each schedule in many pharmacology texts
Schedule II
currently accepted medical use in U.S. with hig abuse potential resulting in severe physical o psychological dependence
Rules for Prescriptions
written prescription required with prescriber’s actual (legal) signature Electronic prescriptions are allowed (preferred, required)
must be dated the same day as signed
No refills allowed
In an emergency, verbal order may be given for limited quantity of drugs adequate to treat the emergency condition, but must be followed by a writte prescription within 72 hours. Note: This provision of federal law is no recognized in Alabama since state law may be more stringent than federa law. THERE ARE NO VERBAL ORDERS ALLOWED FOR SCHEDULE I PRESCRIPTIONS IN ALABAMA.
Schedule II Drugs
Methylphenidate (Ritalin)
• Oxycodone (Oxycontin)
• Morphine
• Meperidine (Demerol)
• Cocaine
• Codeine
• Fentanyl
• Hydrocodone
Schedule III
abuse potential less than Schedule II
1. Rules for Prescriptions
a. written or verbal prescriptions allowed; valid for 6 month from the date written
b. limit of 5 refills
Schedule III Drugs
Codeine/Acetaminophen (Tylenol #3)
Anabolic steroids
Sedatives like Secobarbital
Schedule IV
abuse potential less than Schedule III (sam rules)
Examples:
1.Benzodiazepines, e.g., diazepam (Valium), Alprazolam (Xanax) 2. Drugs for weight loss (Qsymia)
2.Drugs for sleep (Ambien)
Schedule V
Lowest abuse potential
some drugs in this schedule are nonlegend both federally an in some states; purchase still subject to state regulations
2. antitussive and antidiarrheal narcotic drugs in limite quantities, e.g,. diphenoxylate/atropine (Lomotil), Robitussin-AC
3. narcotic analgesic: buprenorphine (Buprenex)
Rules for Controlled Substances in Alabama
Classifications determined by the State Board of Health, bu
may not be classified in lower schedules than federal la permits
Poison Prevention Packaging Act (1970)
regulates certain “household substances” and requires tha they be packaged for consumer use in a
manner that will make them significantly difficult for children < 5 y to open
2. patient may request noncomplying container
3. child-resistant container applies to:
a. all controlled drugs
b. all legend drugs except
i. sublingual nitroglycerin
ii. oral contraceptives in dispenser packs
c. aspirin or aspirin-containing preparations; som exceptions, e.g., effervescent tablets
d. iron-containing drugs and dietary supplements; som exceptions
Food and Drug Administration Modernization
Act (FDAMA) 1997
Allows for fast-tracking of drugs for serious illnesses to market
Drug manufacturers have to give patients 6 months notice before they discontinue making a drug
Established a clinical trial database for drugs for critical illnesses
Informs of “off-label” uses
Incentives for pediatric drug research
Best Pharmaceuticals for Children Act (BPCA) 2002
Pediatric Research Equity Act 2003
Both promote drug studies in children
See how existing drugs work in children and
determine safety
Set up pediatric drug trials
FDA Amendments Act 2007
Drug safety legislation designed to monitor drugs once they are on the market
Post-marketing safety, risk surveillance
mandated to include 100 million patients
Black Box Warnings—high risk!!
Risk Evaluation Mitigation Strategies
Dear Prescriber Letters
Removal of unsafe drugs from the market quickly
Enteral routes
oral, sublingual,
rectal
a. oral (peroral, po)
b. sublingual (sl) - tablets placed under
tongue and allowed to dissolve c. rectal (pr)
Parenteral routes
Injectables
a. general considerations
i. requires sterile dosage forms
ii. faster onset of action
iii. skill and training required for injection iv. used for drugs which do not undergo GI
absorption, or which are unstable in the GI tract b. intravenous (iv)
c. intramuscular (im)
d. subcutaneous (sc; subQ)
Oral Administration
Advantages
relatively safe
convenient
suited for slow-release dosage forms systemic or local effects in GI tract
Disadvantages
delayed onset of action
GI distress
swallowing or tube feeding taste
food interactions inactivation by gastric acid first-pass effect
take with water
schedule in relation to meals
Oral
Formulations
liquids: solution, elixir,
syrup, suspension (shake well before measuring dose)
solids: capsules, tablets- film coats - enteric coats- crushing
Sublingual, Buccal Administration
Advantages:
– rapid absorption and onset- directly absorbed
into blood- avoids exposure to gastric acid and first-pass effect
• Disadvantages:
– must not be irritating or have bad taste- must
not swallow tablet or drink liquid while tablet is in place- keep under tongue or in buccal cavity until completely dissolved
Rectal Administration
Advantages:
suitable for NPO patient systemic or local action may avoid first-pass effect
Disadvantages
inconvenient, noncompliance
Dosage forms: suppositories, retention
enemas
Intravenous Administration
Advantages
most rapid-acting
may control and titrate dosage relatively large volumes complete absorption
Disadvantages
requires skill for administration
cannot recall administered drug (most hazardous route)
requires water-soluble drug
